GUEST COLUMNISTS

• Unlocking The Future Of Cell And Gene Therapies

  We took the opportunity to speak with some BioPhorum members about issues such as emerging technologies, regulatory challenges, and engagement with regulators in the advanced therapy medicinal products (ATMP) space.

• What Goes Into Restarting A Shelved Orphan Drug Candidate?

  The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.

• A Much-Improved Approach For Understanding And Managing Safety Risks

  Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

• CSV Assumes The AI System Sits Still — It Doesn't.

  The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

• July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing

  Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

• In Bioprocessing, Trusted Data Is A Process Variable

  As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.

• Combination Cell Therapy's Clinical Success Hinges On Manufacturability

  Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.

• Are Biopharma Companies Outsourcing Their Ability To Think?

  Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.